Actively Recruiting
Randomized Trial of Nivolumab Plus Paclitaxel and Ramucirumab vs Paclitaxel and Ramucirumab Alone in Advanced Gastric and Esophageal Adenocarcinoma
Led by National Cancer Institute (NCI) · Updated on 2026-05-26
224
Participants Needed
371
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying advanced stomach or esophageal adenocarcinoma to see if adding the drug nivolumab to the usual treatment of paclitaxel and ramucirumab improves outcomes for patients. This phase IIIII trial compares the combination of nivolumab, paclitaxel, and ramucirumab with paclitaxel and ramucirumab alone. The study aims to assess progression-free survival and overall survival, while also evaluating response rates, disease control, safety, and quality of life. Participants are randomly assigned to one of two groups. One group receives nivolumab intravenously on day 1 of each 28-day cycle, along with ramucirumab on days 1 and 15, and paclitaxel on days 1, 8, and 15. The other group receives ramucirumab and paclitaxel on the same schedule without nivolumab. Treatments continue unless the disease progresses or unacceptable side effects occur. Patients may also have optional blood tests, CT scans, and MRIs during the study. Throughout the trial, participants undergo regular imaging scans and optional blood sample collection to monitor disease status. After treatment ends, follow-up visits occur at 30, 60, and 90 days, then every 6 months for up to 3 years to assess survival and health. Researchers also collect patient-reported outcomes related to symptoms and quality of life during the study period.
CONDITIONS
Brief Title
Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have advanced or locally unresectable gastric, gastroesophageal junction, or esophageal adenocarcinoma
- PD-L1 Combined Positive Score (CPS) must be 1 or higher
- Histologically confirmed microsatellite stable and HER2 negative diagnosis
- Documented unresectable and/or metastatic disease confirmed by CT or MRI
- Treated brain metastases must be stable with no progression after CNS therapy
- Disease progression or intolerance to frontline chemotherapy plus PD-1/PD-L1 inhibitor
- No more than one prior line of systemic therapy including PD-1/PD-L1 inhibitor in advanced setting
- No systemic corticosteroids over 10 mg prednisone equivalents within 14 days before registration
- No prior significant immune-related adverse events requiring immunotherapy discontinuation
- No live attenuated vaccine within 28 days prior to registration
- No major surgery within 28 days or venous access device placement within 7 days prior registration
- Fully recovered from prior surgery effects; no recent bleeding or wound complications
- No planned major surgery during the trial
- No active bleeding or recent significant gastrointestinal bleeding or perforation
- No concurrent cancer treatments other than study drugs
- No history of severe allergic reactions to monoclonal antibody therapy
- Age 18 years or older
- Zubrod Performance Status 0-2
- Adequate blood counts and organ function within 28 days prior to registration
- Adequate cardiac function with New York Heart Association class 2 or better
- No recent arterial thromboembolic events within 6 months
- Controlled blood pressure
- HIV positive participants must be on effective therapy with undetectable viral load
- Controlled hepatitis B or cured hepatitis C infection
- No prior or concurrent malignancy that may interfere with study
- Not pregnant or nursing and using effective contraception if of reproductive potential
- No active autoimmune diseases or recent pneumonitis requiring steroids
- Willing to participate in specimen banking and quality of life assessments
- Able to give informed consent according to regulations
You will not qualify if you...
- More than one prior line of systemic therapy including PD-1/PD-L1 inhibitors in advanced setting
- Use of systemic corticosteroids over 10 mg prednisone equivalents within 14 days before registration
- Prior significant immune-related adverse events requiring stopping immunotherapy
- Live attenuated vaccine within 28 days prior to registration
- Major surgery within 28 days or venous access device placement within 7 days before registration
- Postoperative bleeding or wound complications within last 8 weeks
- Planned major surgery during the trial
- Active bleeding or significant gastrointestinal bleeding or perforation within 84 days prior to registration
- Concurrent chemotherapy, immunotherapy, investigational agents, biologic or hormonal therapy outside study drugs
- History of grade 3 or 4 allergic reaction to humanized or human monoclonal antibody therapy
- History of grade 3 or 4 immunotherapy toxicities except controlled hormonal abnormalities
- Pregnant or nursing individuals
- History of inflammatory bowel disease or symptomatic autoimmune diseases
- History of pneumonitis requiring steroids within last 12 months
- Uncontrolled blood pressure
- Recent arterial thromboembolic events within 6 months prior to registration
- Prior or concurrent malignancy that may interfere with study assessments
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